Shaped load-bearing osteoimplant and methods of making same

Inactive Publication Date: 2007-10-04
WARSAW ORTHOPEDIC INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0007] It is an object of the present invention to provide an osteoimplant possessing s

Problems solved by technology

The range of bone grafts that might be thus prepared is limited by the size and shape limitations of the bone tissue from which the bone graft originated.
Certain clinically desirable shapes and sizes of grafts may thus be unattainable by the cutting and shaping processes, due to the dimensional limitations of the bone.
For some shapes they may also be available only in limited amounts, due to the large variations inherent in the human or animal donor source populations.
Many structural allografts are nev

Method used

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  • Shaped load-bearing osteoimplant and methods of making same
  • Shaped load-bearing osteoimplant and methods of making same
  • Shaped load-bearing osteoimplant and methods of making same

Examples

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Effect test

example 1

[0150] Elongate bone particles were prepared using a milling machine. Half of the volume of the particles was fully demineralized using two changes of 0.6N HCl acid. The nondemineralized and the fully demineralized particles were then combined together in an aqueous solution containing glycerol and allowed to soak for 4-12 hours at room temperature. The particles were then removed from the solution by straining, and placed into a 28 mm diameter cylindrical press-mold while still moist. The particles were pressed to 10,000 psi for 15 minutes. The resulting compressed pellet was heated in situ in an oven for 4 hours at 45° C. The osteoimplant was then frozen in a −70° C. freezer (1.5 hours), and freeze-dried overnight, after which it was removed from the mold. The bulk density of the osteoimplant produced was 1.34 g / cm3. The height of the osteoimplant was 29 mm. The wet compressive strength of the osteoimplant exceeded 3 MPa.

example 2

[0151] The procedure of Example 1 was used except the ratio of fully demineralized to nondemineralized bone particles was 2:1, the pellet was heated in situ in an oven for 4 hours at 40° C. and the pressure was 2,500 psi. The resulting compressed pellet was cut into two portions and each portion was treated with crosslinking agent: 10% neutral buffered formalin (both dipped and in vapor phase) and 4% Denacol EX313 (a polyepoxy-ether compound available from Nagase America Corp., New York, N.Y.), respectively. In each case, the resulting osteoimplant swelled a little and became stiff, and resistant to manual pressure. The bulk density of the osteoimplant produced was 1.2 g / cm3. The wet compressive strength of the osteoimplant exceeded 3 MPa.

example 3

[0152] The procedure of Example 1 was followed except that all of the particles were partially demineralized by using 225 ml of 0.6N HCl and allowing the acid to react to depletion. Additionally, the mold was hexagonal in configuration (with each side of the hexagon measuring 18 mm). After completing the freeze-drying step, the resulting osteoimplant was placed in a bath of 10% neutral buffered formalin and the exposed collagen of the partially demineralized bone particles was allowed to cross-link for 48 hours. The resulting dry osteoimplant was tested mechanically and was found to possess a dry compressive strength of about 85 MPa. The bulk density of the osteoimplant was 1.05 g / cm3.

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Abstract

A load-bearing osteoimplant which comprises a shaped, coherent aggregate of bone particles.

Description

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. patent application Ser. No. 10 / 736,799, filed Dec. 13, 2006; which is a continuation-in-part of U.S. patent application Ser. No. 10 / 229,767, filed Aug. 27, 2002, now U.S. Pat. No. 6,696,073; which is a continuation-in-part of U.S. patent application Ser. No. 09 / 911,562, filed Jul. 24, 2001, now U.S. Pat. No. 6,440,444; which is a continuation of U.S. patent application Ser. No. 09 / 256,447, filed Feb. 23, 1999, now U.S. Pat. No. 6,294,187; each of which is incorporated herein by reference.FIELD OF THE INVENTION [0002] This invention relates to osteoimplants and their use in the repair of bone defects and injuries. More particularly, the invention relates to a load-bearing composite osteoimplant which can assume any of a wide variety of configurations, methods for their manufacture and the use of the osteoimplants for the repair of hard tissue. BACKGROUND OF THE INVENTION [0003] Shape or cut bone...

Claims

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Application Information

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IPC IPC(8): A61F2/28A61F2/44A61F2/30A61L27/36A61L31/00
CPCA61B17/0401A61B17/72A61B17/74A61B17/80A61B17/86A61B2017/0409A61B2017/0414A61B2017/044A61C8/0012A61C8/0036A61F2/28A61F2/2803A61F2/2875A61F2/30965A61F2/32A61F2/34A61F2/36A61F2/442A61F2/446A61F2/4611A61F2/4644A61F2002/2817A61F2002/2825A61F2002/2835A61F2002/2871A61F2002/2892A61F2002/30004A61F2002/30059A61F2002/30062A61F2002/30113A61F2002/30125A61F2002/30143A61F2002/30146A61F2002/30148A61F2002/30153A61F2002/30154A61F2002/30158A61F2002/30225A61F2002/30237A61F2002/30238A61F2002/30261A61F2002/30266A61F2002/30433A61F2002/30561A61F2002/30622A61F2002/30678A61F2002/30785A61F2002/3085A61F2002/3092A61F2002/3095A61F2002/30952A61F2002/30957A61F2002/30962A61F2002/30968A61F2002/3611A61F2002/365A61F2002/3686A61F2210/0004A61F2220/0041A61F2230/0006A61F2230/0008A61F2230/0017A61F2230/0019A61F2230/0021A61F2230/0026A61F2230/0069A61F2230/0082A61F2250/0014A61F2250/0071A61F2310/00011A61F2310/00161A61F2310/00173A61F2310/00293A61F2310/00347A61F2310/00365A61L27/3608A61L27/3641A61L27/3683A61L27/3691A61L27/3839A61L27/3847A61L31/005A61L2430/02A61F2002/30677A61F2002/30948
Inventor BOYCE, TODD M.SHIMP, LAWRENCE A.MANRIQUE, ALBERTWINTERBOTTOM, JOHN W.
Owner WARSAW ORTHOPEDIC INC
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